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Stable Acyclovir Sodium Parenteral Formulation

a technology of acyclovir sodium and parenteral formulation, which is applied in the field of parenteral formulation of acyclovir sodium, can solve the problems of limited success of the initial preparation, and achieve the effect of improving the stability and efficacy of the initial preparation

Pending Publication Date: 2022-02-10
RK PHARMA SOLUTIONS LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present patent application describes a new formulation of Acyclovir sodium for use as an anti-viral drug. The formulation is a stable injectable liquid that can be stored for a long time without losing its effectiveness. The technical effects of this invention are the increased stability and ease of use of the drug, allowing for longer periods of safe and effective treatment.

Problems solved by technology

But due to complexity associated with lyophilised powder, ready to use solution is developed.
Although, previous attempts have been made to improve the delivery and bioavailability of Acyclovir, these attempts have had limited success.

Method used

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  • Stable Acyclovir Sodium Parenteral Formulation

Examples

Experimental program
Comparison scheme
Effect test

example 1

Manufacturing Formula:

[0034]

Sr.noIngredientsQuantity1Acyclovir sodium700 mg20.9% NaClq.s. 100 mL

Manufacturing Procedure:

[0035]Step 1: 700 mg of acyclovir sodium was weighed and transferred to a manufacturing vessel.

[0036]Step 2: 0.9% NaCl solution (90 ml) was added to the acyclovir sodium in the above step and the mixture was stirred till it became clear.

[0037]Step 3: the pH of the solution was checked and adjusted as necessary to between 8.5 to 10.

[0038]Step 4: total volume was increased to 100 ml by adding 0.9% NaCl solution.

[0039]Step 5: the clear solution was used to fill an infusion bag made of polypropylene or polyvinyl chloride or LDPE bags or combination of polymer extrudes.

[0040]Step 6: The formulation was then stored at 25° C.±2° C. / 60% RH±5% RH and at 40° C.±2° C. / 75% RH±5% RH.

[0041]The Acyclovir formulation was then tested for stability at long term (25° C.±2° C. / 60% RH±5% RH) and at accelerated condition (40° C.±2° C. / 75% RH±5% RH) for 3 Months. The following stability ...

example 2

Manufacturing Formula:

[0043]

Sr.noIngredientsQuantity1Acyclovir sodium700 mg2Lactated ringer solutionq.s. 100 mL

Manufacturing Procedure:

[0044]Step 1: 700 mg of acyclovir sodium was weighed and transferred to a manufacturing vessel.

[0045]Step 2: a lactated Ringer's solution (90 ml) was added to the acyclovir sodium in the above step and the mixture was stirred until it became clear.

[0046]Step 3: the pH of the solution was checked and adjusted as necessary to between 8.5-10.0.

[0047]Step 4: total volume was increased to 100 ml by adding a lactated Ringer's solution.

[0048]Step 4: the clear solution was used to fill an infusion bag made of polypropylene, polyvinyl chloride or LDPE bags or combination of polymer extrudes.

[0049]Step 5: the formulation was then stored at 25° C.±20 C / 60% RH±5% RH and at 40° C.±20 C / 75% RH±5% RH.

[0050]This Acyclovir formulation was tested for stability at long term (25° C.±2° C. / 60% RH±5% RH) and at accelerated condition (40° C.±2° C. / 75% RH±5% RH) for 3 Month...

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Abstract

The present application provides method for formulating and corresponding liquid parenteral formulations that include a desired amount of acyclovir sodium added to a vessel with a pharmaceutically acceptable infusion diluent, which are stirred to provide a shelf stable injectable solution.

Description

FIELD OF THE INVENTION[0001]The present application relates to the preparation of parenteral formulations of Acyclovir sodium. In particular, present application relates to the preparation of Acyclovir sodium formulation in IV bags. Present application also relates to the use of this formulation in the treatment of viral infections of the skin and mucous membranes.BACKGROUND OF THE INVENTION[0002]Acyclovir is a synthetic nucleoside analog active against herpesviruses. Acyclovir sodium is a white, crystalline powder with the molecular formula C8H10N5NaO3 and a molecular weight of 247.19. The maximum solubility in water at 25° C. exceeds 100 mg / mL. The chemical name of acyclovir sodium is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one monosodium salt; it has the following structural formula:[0003]Acyclovir sodium was initially approved as lyophilised powder. But due to complexity associated with lyophilised powder, ready to use solution is developed. In sterile lyophil...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/522A61K47/02A61K9/00
CPCA61K9/08A61K9/0019A61K47/02A61K31/522A61K47/12
Inventor KOVI, RAVISHANKERKASU, RAGHUREDDY, THUPALLI AJEYKUMARYEKKANTI, VAMSHI
Owner RK PHARMA SOLUTIONS LLC